Tissue, expansion and approximation device

ABSTRACT

A device applies continuous tension to skin adjacent an ulcerative area, to expand and approximate this skin until it covers the ulcerative area. The new device includes a frame which defines a path in which sliders move under the force of a constant tension spring. Each slider includes a hook-like element that engages and pulls the skin until the skin on opposite sides of the ulcerative area comes together. This element is curved, thus defining a plane which is oriented perpendicular to the path of the slider.

BACKGROUND OF THE INVENTION

This is a continuation-in-part application of U.S. Ser. No. 08/181,762now U.S. Pat. No. 5,507,775 filed Jan. 21, 1994 by the sameco-inventors.

This invention is in the field of medical devices and techniques fortreating and healing open pressure sores, decubitus ulcers, venousulcers and other wounds and more specifically for encouraging growth,regeneration and expansion of skin to cover such open wounds.

Pressure sores or decubitus ulcers are frequently encountered clinicalproblems. High risk patients are the elderly, diabetics, those withspinal cord injuries and patients requiring prolonged bed rest. Inpatients at high risk, prolonged pressure may lead to gangrenouschanges. In diabetic patients foot problems are common and result inextensive hospitalization, disfiguring surgery, lifetime disability anddiminished quality of life. In 1987 at least 56,000 diabetic individualshad at least one major limb amputation. In five years 50% will lose thesecond limb. The financial burden of amputation is enormous.Complications from foot problems are the cause of 20% of all diabeticadmissions to hospitals. Approximately 10% of the diabetic population(5-10 million people) will be affected at some time in their lives withdecubitus ulcers and foot problems.

A pressure ulcer usually develops when soft tissue is compressed betweena bony prominence and a firm surface. When this pressure is above 32 mmHg blood capillaries close. If this pressure is applied long enough thevessels thrombose. This development occludes blood flow, deprives tissueof oxygen, nutrients and waste removal paths, and leads to cell death organgrene.

In the foot pressure ulcers are usually seen on the heel, metatarsalhead, lateral border of the foot, midfoot, ankle and digits. Ulcerslocated on the heel and in the midfoot region are particularly resistantto successful treatment, midfoot ulcers having an amputation rate of 39%versus 6.8% in forefoot ulcers.

Pressure ulcers are also a serious and common complication of immobileelderly persons and patients with cerebral injuries such as paraplegics,quadraplegics, multiple sclerosis and strokes. The incidence of pressureulcers in the elderly is 3% to 29% in acute care hospitals and nursinghomes. Quadraplegics have an incidence of 60%. The cost of pressureulcer treatment is substantial; estimates range from $4,000. to $40,000.per pressure ulcer. A pressure ulcer develops as a result of prolongedpressure on the bony prominences of the sacrum, trochanter and ischium.

Venous ulcers of the lower extremities afflict 1% of the generalpopulation and 3.5% of persons over 65 years of age, with a recurrencerate approaching 70%. Venous ulcers result from disorders of the deepvenous system. When forward flow of venous blood is significantlydisturbed or impaired, venous dysfunction ensues which result inincreased hydrostatic pressure, venous hypertension, edema andultimately, dermal ulceration. Venous ulcers are commonly found on themedial aspect of the leg.

Treatment of an ulcer includes removal of pressure on the ulcer,application of appropriate local dressings, medication and removal ofnecrotic tissue. Alternative approaches include topical growth factorsand skin replacement. A recent study found poor healing to be acontributing cause in 81% of amputations in diabetic patients. TheNational Center for Health Statistics indicates an average of 20inpatient days for persons hospitalized with skin ulcers.

Pressure ulcers or venous ulcers are difficult to heal. These ulcers arenot surgical or incisional wounds; they require skin replacement. Asurgical or incisional wound is made in normal healthy tissue, where thetissue is not contaminated, there is no underlying disease process, andthe skin is easily stretchable. An ulcerative wound is alwayscontaminated and often infected. There is an underlying disease processthat causes the ulcer. Typically there are arterial, venous, lymphaticand neurologic problems and tissues are immuno-compromised by blooddiseases or diabetes. Ulcerated tissues are fixed and rigid and oftenlie on and are adherent to the bone, tendon or joint.

Pressure ulcers are graded by the degree of damage to tissue observed. Astage III and stage IV pressure ulcer involves full thickness skin lossexposing subcutaneous tissue and underlying fascia. Stage IV pressureulcers involve muscle, bone or supporting structures. These lesions witha deficiency of skin are treated by methods that encourage healing andclosure of the defect. In some instances it is not possible to obtaincomplete coverage of the lesion. In any event healing by naturalmethods, growth factors or skin grafts results in a thin fragile layerof epidermal skin cover that is less well suited to the rigors ofeveryday life and has a tendency to breakdown.

The skin of the body has unique characteristics depending upon itslocation. The skin of the foot differs from facial skin. The skin of thefoot is significantly thicker, adherent to the underlying tissues andsupplied with elastic cushions of adipose tissue. It is so specializedto withstand the forces that act upon it that it is virtuallyirreplaceable. Skin grafts and flaps derived from other locations havedifficulty tolerating the pressure and friction involved in the functionof the foot. Skin grafts and growth factors basically replace part ofthe epidermis. They do not replace the dermis of the skin in whichresides an elaborate vascular network and specialized arteriovenousshunts; the dermis is responsible for the ability of the skin towithstand the pressures and traumas of daily living.

The ideal wound closure would be one that can be closed at the localsite with full thickness skin (epidermis and dermis). In most pressureulcers and venous ulcers it is not possible to approximate the skinedges due to the size of the wound. Attempts to pull skin together undertension with the use of sutures results in strangulation of the bloodsupply of the sutured skin or the tearing of the suture through theskin.

SUMMARY OF THE NEW INVENTION

The new Ger-Oddsen device takes advantage of the natural elasticity ofskin by the application of a constant force on the edges of the wound.Over a period of time the wound is covered with new full thickness skin.The Ger-Oddsen device both approximates the edges of the wound andcreates additional skin to cover the wound. When skin has a constantforce applied to it, it has the capacity to progressively stretch tocreate additional skin coverage as is demonstrated in such naturalevents as pregnancy, obesity, the development of tumors and the growthprocess as one ages from a child to an adult. The origin of theadditional skin involves the generation of new tissue, the stretch ofpreexisting tissue and the recruitment of adjacent tissue. This newlystretched skin has enhanced vascularity and viability. Studies indicatethat a constant force exerted on endothelial cells acts as a stimulusfor angiogenesis and is one of the mechanisms responsible for theneovascularization associated with newly stretched skin.

The Ger-Oddsen device consists of two large staples or needles, each ina separate holder. These holders are attached to each other by aconstant force Negator® spring. These holders ride in a track thatfollows the approximate shape of the contour lines of the bonyprominence at the site of the ulcer. Different shaped tracks would beused for ulcers of the heel, ankle, lateral and medial border of thefoot, top of the foot, sacral, trochanteric and ischial areas.Contingent upon the size and location of the ulcer one or more orcombinations of the above would be used. The surface of the device thatmakes contact with the skin and ulcerative area is covered with apressure absorbing material to prevent the development of pressurenecrosis of the skin by the device.

The new device is used by extending the Negator® spring until theholders are brought to the outer stops. The large staples are insertedinto the healthy skin tissue near but outside the edges of the ulcer.The staples are of a length that penetrates and grasps epidermis, dermisand subcutaneous tissue. The staples each have a sharp point and arecurved at the end for easy penetration of tissue. The staples arepositioned in their holders at an angle that applies a downward force onthe surface of the skin. The constant force applied by the Negator®spring onto the staples results in approximation and the development orgeneration of full thickness skin which covers the wound over a periodof time.

The prior art includes, for example, a U.S. Pat. No. of Life MedicalScience which concerns closure of wounds generally, but differs from theGer-Oddsen device in its fundamental objectives and results. While theGer-Oddsen device and the Life Medical Sciences device both recognizethe stretching qualities of skin, they are utilized for closure ofdifferent type of wounds. Life Medical Sciences' device is used to closeshort-lived primary wounds, namely a wound caused by trauma or thatoccurs at surgery. Recent wounds lend themselves to easy approximationas the wounds are not fixed by chronic inflammatory changes.

The Ger-Oddsen device utilizes the delayed closure approach to heal longterm chronic non-healing wounds such as decubitus and venous ulcers. Itis designed to encourage the closure of the wound by a limited and muchsmaller magnitude of constant force over a period of days or weeks. Thislimited amount of force prevents the diminution of blood supply to theaffected area. There is time for the edema to disperse and thecontaminated area can be debrided and treated medically.

Another significant difference in the Ger-Oddsen device is that itautomatically creates additional full thickness skin coverage of thewound over a period of time and permits debridement of necrotic tissueand treatment with medication at the discretion of the physician. Theliterature of Life Medical Sciences skin-stretching device indicatesthat the tissue edges are brought together by the manual application offorce over a shorter period of time.

The Ger-Oddsen device applies a constant force on local site skin thatstretches and induces new skin growth to provide replacement skincoverage for the decubitus ulcer. This force is constant even as thereplacement skin expands to cover the wound. A compression or extensionspring would lose its force as the skin expands. Thus, in the LifeMedical Sciences technique the tension force applied to stretching skinis cyclic from great at the beginning of each cycle to small as the skinstretches and before a new high force setting is established.

In the Ger-Oddsen device less force is needed to achieve the same amountof stretch when skin is continuously stretched by a constant force. Inthe Ger Oddsen device there is a continuous process of incremental lowforce stress-relaxation of the skin that allows tissues with poorextensibility quantities and compromised vascular supply such as thelower extremities to be expanded without losing its viability. Highforces constrict small blood vessels with a consequent reduction inblood flow to the area. A low force minimizes tissue ischemia. Low forcealso minimizes microfragmentation of elastin and collagen fibers.

In the Ger-Oddsen device the force is preset to a value below that ofcapillary circulation pressure. Manual or random application of forcecan result in forces exceeding capillary circulation and lead toischemic conditions. In areas of compromised blood supply such as thelower extremities this limitation of maximum force is of criticalimportance. Note, the Life Medical Sciences device is used in areaswhich are highly vascularized.

The constant force of the Ger-Oddsen device also stimulates angiogenesisresulting in a full thickness skin coverage over the ulcer that now hasenhanced vascularity. This increased blood flow with enhanced oxygen andnutrients leads to quicker healing of the decubitus ulcer.

Life Medical Sciences skin-stretching device provides only one axis ofmotion, i.e. linear or planar motion. Pressure ulcers occur over bonyprominences that are usually not linear but curved or rounded. TheGer-Oddsen device provides for two axes of motion that follows thenatural shape of the contour lines of the bony prominence at the ulcersite.

Two-axis motion permits full thickness skin replacement in two differentdirections simultaneously. In the Ger-Oddsen heel ulcer device, forexample, full thickness skin is created in the vertical and horizontaldirection simultaneously. In the Ger-Oddsen border ulcer device fullthickness skin is created from the top and bottom of the footsimultaneously. In this application two-axis motion means that thedevice may pull skin in a curved direction following the natural contourof the foot or buttock, for example. Thus, instead of being limited tostraight-line, single axis or planar motion, the device pulls the skinaround a curve, while maintaining a continuous tension. This pullingalong a curved path has been designated herein as two-axis or multi-axismotion as skin is expanded to cover the three-dimensional configurationof the ulceration. With a Negator spring this device maintains acontinuous force of constant magnitude.

In instances where there is a significant difference in the elasticityof skin the device would have a constant force spring of one value onone axis and a constant force spring of another value on the other axis.

Ger-Oddsen's two-axis motion insures adhesion of tissue layers duringtissue expansion process. This is highly beneficial, because a decubitusulcer is a contaminated area and any separation of tissue layers duringthe expansion process would allow an infection to develop under theexpanded skin layer.

In a still further embodiment of the Ger-Oddsen invention, as the devicecloses the wound there is a ratcheting mechanism that preventsretrogressive movement of the staples.

In a still further embodiment of the Ger-Oddsen invention which includesthe above-noted constant force staple and the ratcheting mechanism,healing time can on occasion be accelerated by an initial application ofmanual force to close the wound that is greater than the constant forceapplied to the wound margins by the device. Initially the sliders of thedevice are manually moved towards each other until significant tissueresistance is encountered; this quickly closes the wound as far aspossible. The manual force is then released from the sliders and thestaples are prevented from retrogressive movement by a ratchetingmechanism. Upon disengagement of the manual force, the constant force ofthe device is instantaneously applied to the wound margins until thewound closes.

In a still further embodiment of the Ger-Oddsen invention, the staplesare oriented in the sliders at a 90 degree angle to the frame of thedevice. The orientation of the curved end of the staple parallel to thewound margin distributes the stretching force over a broader surfacearea.

The objective of the Ger-Oddsen device is to obtain as much fullthickness skin over the ulcerative site as possible. Presently thiscannot be achieved by natural methods, as re-epithelialization onlyresults in a fragile layer of skin thickness without dermis. Splitthickness skin grafts used to cover large ulcerative wounds also resultin a tenuous layer of skin thickness without dermis. In the 1970's thedeficiencies of these methods ushered in an era of muscle flaps forclosure of pressure ulcers. This is basically the transfer ofmusculo-cutaneous flaps (epidermis, dermis, sub-cutaneous tissue andmuscle) from a donor site to the ulcerative site to allow a tension freeclosure and better skin cover. While the initial operative success of80% is achieved at surgery, studies indicate 69% of the patients had arecurrent ulceration within a mean of 9.3 months.

Another prior art technique is to surgically place an inflatable balloonsub-cutaneously. After a time period for the surgical wound to heal theballoon is inflated to a pressure which stretches the skin. Pressure andvolume of the balloon is increased by incremental injections of sterilesaline into the balloon over weekly time periods so as to createadditional new skin. When a sufficient amount of skin to cover theulcerative site is created the inflatable balloon is removed surgically,the new skin incised and the donor site closed by suture. The suture ofthe new skin to the ulcerative site results in a tension free closure ofthe wound.

The Ger-Oddsen device applies a continuous constant diminutive force onskin over a substantial time period to create additional new skin. Theresult is newly created additional local site skin somewhat related butsignificantly superior to results from the existing tissue expansioncyclic process. The end result of this new tissue expansion andapproximation process is a tension free junction of the opposing tissueedges of the ulcerative wound with new local site full thickness skin.

In the prior art Life Medical Sciences device the tissue edges arebrought together under high tension applied for a short period of time,and the tissue edges are sutured together. However, the force appliedcyclically varies from high at first to low as the skin sketches, andthen high again as the device is periodically readjusted.

Tissue expansion with known expanders has a 38% complication rate.Tissue expansion by prior devices in the lower extremity and the footrequires a long time period. There is a time period for the incision ofthe first surgical procedure (placement of expander) to heal and to bestrong enough to withstand the forces of tissue expansion. Incisionaldehiscence and exposure of the expander is a major complication oftissue expansion. This is caused by starting the expansion process toosoon or too great an insufflation pressure of the expander. The typicalmethod of determining expansion pressure is measured by pain responsefrom the patient; the pressure is then reduced. In the foot the timeperiod from the first surgical procedure to the second surgicalprocedure can be as long as 12-16 weeks.

Complications such as leakage of fluid, necrosis of skin, hematoma andspontaneous deflation of expander occur resulting in abandonment of theprocedure. These prior tissue expanders result in the separation oftissue layers around the edges of the expander. At the margin of theexpander, the skin has been raised and oriented at right angles to thelayer of underlying tissue. Therefore, the pulling force produced byballoon inflation causes these layers to separate. The frequency ofpercutaneous injections of sterile saline to increase expander pressurepredisposes these areas to infection. Infection of the implant cavity isserious resulting in removal of the expander.

Prior tissue expanders sacrifice the well being of the donor site to theneed of the recipient site. The donor site suffers aesthetic loss in theform of scars and may suffer functional loss as well. Patients have totolerate the embarrassment, inconvenience and the temporary deformity ofthe inflated balloon during the tissue expansion process site.

Extreme care must be taken in the selection of the donor site. Theexpander must be placed over a firm surface (muscle tissue or bone) thatresists mechanical deformation and directs the force of expansionoutward, towards the overlying soft tissues. A force is placed on themuscle tissue and bone under the expander. Nerves may become trappedunder the expander (paresthesia from compression of peripheral nerves).Muscle tissue under the expander forms a bath-tub depression as itconforms to the expander and atrophies. In some instances there has beena significant reabsorption of bone directly under the expander. If theexpander is placed too close to the ulcer the wound increases as theexpansion process proceeds.

The expander is an implanted foreign body. Particles from the expanderdelaminate or flake from the surface of the expander into the tissuecausing inflammatory reactions.

In folded skin expanders the expander is not flat in the non-expandedstate. Dog ears occur during expansion when the folded skin expanderdoes not expand properly.

The Ger-Oddsen device is a directional tissue expansion device. Itexpands tissue in the direction and over the ulcerative wound. There areno surgical procedures with Ger-Oddsen device. This eliminates the risksof surgery, general anesthesia, hematoma, etc.

The Ger-Oddsen device applies a continuous constant force to the skin.Constant force to the skin has been demonstrated to expand more tissuethan the intermittent application of force. Continuous tissue expansionachieves the most rapid rate of expansion possible while stillpreserving the structural integrity and viability of the skin.

When skin is pulled in the same plane as the skin and the expansiondevice follows the contour of the bony prominences, it is unlikely thatseparation between skin and fascial layers will occur. A decubitus ulceris a contaminated area; any separation of tissue layers (as withexisting tissue expanders) during the expansion process may allow aninfection to develop under the expanded skin layer.

There is no donor site. There are no flaps to suture to the recipientsite. With the Ger-Oddsen device a sutureless closure of the wound ispossible; as it creates skin it brings the opposing edges of the woundto an abutting relationship where the healing process takes place.

A further embodiment of the new device includes means for the localinjection of medication or anticontractile agents into the tissue.Anticontractile agents (papaverine) enhance tissue expansion byfacilitating tissue relaxation. Stretching the dermis results in theappearance of contractile fibroblasts. Anticontractile agents reducethese fibroblasts enabling the dermis to be more easily stretched withepidermal proliferation maintaining an adequate surface layer over theexpanding dermis. Papaverine also increases post expansion blood flow.This may be the result of the local drug effects on the vasculatureleading to vasodilation and an increase in perfusion. In the Ger-Oddsendevice the staple, if fabricated from thin-walled tubing, may functionalso as a hypodermic needle through which may be injected medicationincluding muscle relaxants, anesthetics or antibiotics oranticontractile agents into the tissue.

The new device achieves wound approximation and the creation of newskin, and significantly new skin that has full or relatively fullthickness of original local site skin as compared to techniques such asskin grafts, growth factors or natural methods which cover the woundwith thin epidermis without the underlying dermis or musculo-cutaneousflaps and the existing tissue expansion process that requires surgicalprocedures and donor sites.

The new device engages relatively healthy or non-ulcerative skin on oneor more sides of the ulcerative site and slowly but steadily pulls theedges of healthy or healthier skin toward each other until they coverthe ulcerative site and grow together. Skin is engaged by inserting ahook-like element or prong or staple into the sub-cutaneous layer bypiercing the epidermis and dermis.

In a preferred embodiment of the new device a pair of hooks are situatedon opposite sides of an ulcerated site, these hooks being aimed towardeach other. Each hook is carried by a slider which moves in a path ortrack in a frame. The surface of the device that comes into contact withthe skin or ulcerative area is covered with a pressure absorbingmaterial. A generally constant force of generally constant magnitude isapplied to each hook which force induces the skin including the threelayers identified to move, stretch, develop, and/or regenerate such thatit slowly covers more of the ulcerative area.

On each hook is applied a force that is continuous and generallyconstant in magnitude. The magnitude is adjusted to be sufficientlygreat to achieve the desired results and not too great to cause thehooks to tear the skin or cause tissue ischemia.

The movement of the hooks is achieved by a spring force applied to thehook or to a slider carrying the hook, where the slider is guided tomove along the predetermined path in a frame or in a track on the frame.The frame provides a path in which the sliders move; also, the pathdefines and controls the directional movement of the sliders. Thus, thepath can define a three-dimensional displacement whereby a slide movesabout multiple axes.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a fragmentary illustration of a person's foot showing ulcersat six locations.

FIG. 2A is a schematic plan view showing the new device with a singleslider, prong and spring.

FIG. 2B is a schematic plan view showing the new device with a pair ofsliders, prongs and springs.

FIG. 2C is an enlarged fragmentary view showing a slider and pronginserted into epidermis, dermis and sub-cutaneous layer.

FIG. 3A is a plan view showing a first embodiment of the new device atthe beginning of its application to a "border" ulcer.

FIG. 3B is a plan view showing the device of FIG. 3A at the end of itsapplication to a "border" ulcer.

FIG. 4A is a plan view showing a second embodiment of the new device atthe beginning of its application to a heel or midfoot ulcer.

FIG. 4B is a plan view showing the device of FIG. 4A at the end of itsapplication to a "heel" or "midfoot" ulcer.

FIG. 5A is a plan view showing a third embodiment of the device at thebeginning of its application to a trochanteric, sacral or ischial ulcer.

FIG. 5B is a plan view showing the device of FIG. 5A at the end of itsapplication to a trochanteric, sacral or ischial ulcer.

FIG. 6A is a plan view showing a fourth embodiment of the new device atthe beginning of its application to an ankle ulcer.

FIG. 6B is a plan view showing the device of 6A at the end of itsapplication to an ankle ulcer.

FIG. 7A is a plan view showing a sixth embodiment of the new device atthe beginning of its application to the top of a foot ulcer.

FIG. 7B is a plan view showing the device of 7A at the end of itsapplication to a foot ulcer.

FIG. 8A is a plan view of a seventh embodiment similar to FIG. 4, butwith one slider movable a greater distance than the other slider at thebeginning of its application to an ulcer.

FIG. 8B is a plan view showing the device of FIG. 8A at the end of itsapplication to an ulcer.

FIG. 9 is a schematic view showing a device of FIG. 7 applied to a footshown in cross-section.

FIG. 10 is an enlarged fragmentary view similar to FIG. 2C, but reversedin direction and including ratchet means.

FIG. 11 is similar to FIG. 9 but includes a pressure absorbing materialbetween the device and the patient's skin.

FIG. 12 is a fragmentary illustration of two devices over a wound withthe staple orientation at 90 degrees to the frame of the device.

FIG. 12A is an enlarged detail of FIG. 12.

FIG. 12B is an end elevation of FIG. 12.

FIG. 12C is an end elevation of FIG. 11.

FIG. 13 is a fragmentary illustration of a tool for manual applicationof a force to the sliders of the device.

BRIEF DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 1 show various ulcers and pressure sores further described below.FIG. 2A shows schematically the new concept of a hook 10 carried by aslider 12 movable along a path 14 in a side surface of frame 16. Theframe has a top or outside surface 16T and a bottom or inside surface16B. Slider 12 is pulled by constant force spring 18 which has its leftend 20 secured to hook 10 or to slider 12 and its right 22 end coiledaround post 24 where this post extends transversely of the direction ofpath 14 from its remote end 14R to near end 14N. The spring is acommercially available Negator® spring where its left end 20 applied aconstant force on the slider regardless of how much of the spring'sright end is coiled and therefore regardless of the position of theslider along path 14.

As shown elsewhere, the frame is positioned such that its hookpenetrates the patient's skin when the slider and spring are in theextended positions. The frame is then secured to the patient by tape orother means so that it will be fixed in position on the patient's bodywhile the slider makes its slow traverse of path 14. Alternatively onecould initially position and secure the frame to the patient's body andthen extend the slider and spring for engagement of the hook into thehealthy skin adjacent the ulcerative site.

FIG. 2B shows schematically a more typical version where the singleframe 26 has a pair of paths 27A, 27B with slider 28A, spring 29A andhook 30A movable in path 27A, and slider 28B, spring 29B and hook 30B inpath 27B.

As shown in dotted line, slider 28A moves from its remote or extendedposition P1 to P2 and to its near or final position P3; slider 28A movessimilarly. When hooks 30A and 30B arrive at the near ends of theirrespective paths, they will have pulled remote spaced edges of skin intoapproximation where final joining can occur.

The near ends 27S and 28S of the two paths 27A and 27B constitute stops.If, for example, slider 28A moved to its near end position P3 beforeslider 28B arrived at its near end position, then stop 27S would barfurther motion of slide 28A while slide 28B continued to move toward itsP3 position and its stop 28S. This prevents slider 28A from excessivelypulling, expanding and/or stretching the skin to which it is engaged,especially if this skin extends more quickly or easily or with lessresistance than the skin being pulled by opposite slide.

Obviously, the movement of slider 28A and its hook 30A from position P1to P3 is very slow and generally continuous and may take five or moredays or weeks.

In FIGS. 2A and 2B the layer S is a pressure absorbing material. Thislayer is shown secured to an exposed bottom surface of the frame on allembodiments, but it may be omitted in part or completely in certaininstances, i.e. where the bottom or relevant part of the frame does notcontact or does not have pressure contact with ulcerative areas.Examples of suitable pressure absorbing material are soft andcompressible thermoplastic rubber, adhesive-backed polyester orpolyurethane foam, or a commercially available adhesive-backed topicalhydrogel wound dressing such as Transorb® or Duoderm®.

FIG. 2C shows a fragmentary view of a frame 32 with a path or track 33,and a slider 34 carrying its hook 35. The spring 36 engages a lowerportion 37 of the slider for pulling it in the direction of arrow 38. Asshown in this figure, the hook has penetrated the epidermis, top layer39 of the skin and the dermis, next layer 40, and the next deepersub-cutaneous layer 41. The terminal end of the hook 42 is pointedgenerally in the same direction as arrow 38 which is the direction ofmovement of the slider. Further as seen, the hook 35 has penetrated theskin in an area 43 which is either healthy skin or more healthy than theulcerative cite 44 which is being treated. As will be seen in thevarious embodiments, the track or path may be straight or curveddepending upon the contour or the patient's body part where thetreatment is being conducted.

FIGS. 3A and 3B illustrate another embodiment 50 of the invention whichis applicable to a particular ulcerative site known as border ulcers.Such ulcers are illustrated in FIG. 1 as being on a rounded surface ofthe patient's foot. Here the frame 50 has a concave rounded surface 51corresponding generally to the convex surface 52 of the foot beingtreated. The wavy line 53 on the foot represents the ulcerative areabeing treated, and as seen the hooks 54A and 54B have been introducedinto relatively healthy skin as explained earlier with regard to FIG.2C, so that such skin can be pulled simultaneously by hooks 54A and 54Bto stretch and regenerate new skin to eventually cover the ulcerativearea 53. FIG. 3B shows the same frame 50 where the hooks 54A and 54Bhave in fact moved their full length in their respective paths untilthey have brought the healthy tissue together where it joins along thejunction line 55. Not shown in FIGS. 3A and 3B is an appropriate meansfor attaching frame 50 to the foot. Such attaching means is indicated bythe dotted line 56 which typically could be a tape or gauze dressing orother means for wrapping the device and holding it in this position withrespect to the person's limb.

In the apparatus of FIGS. 3A and 3B a single spring 57 pulls bothsliders 58A and 58B. The spring 57 has a first end 57A fixed to slider58A, and a second end 57B coiled freely about a post 58P of slider 58B,generally as indicated for the spring 18 in FIG. 2A. The sliders movealong paths 59 while spring 57 lies within the frame and along the path.The two sliders are simultaneously urged toward each other, each beingrestrained at a stop 59S in the path from excessive displacement.

FIGS. 4A and 4B show still another apparatus 60 for application of thistreatment to a heal ulcer or a midfoot ulcer where the body contourencompassing the ulcerative site defines generally a 90° curve.Accordingly the frame 60 has a concave curved surface 61 correspondingto the convex ulcerative area 62. As shown the hooks 63A and 63B engagepenetrate and hold healthy skin outward of the ulcerative area.

Similarly as shown in FIGS. 3A and 3B, the present FIG. 4A illustratesthe new device in its initial condition where the treatment is begun,and FIG. 4B shows its final condition where hooks 63A and 63B havetraversed their respective paths 64A and 64B and come together andbrought the healthy skin together at junction line 65.

FIGS. 5A and 5B show a further embodiment 70 of the new device forapplication primarily to trochanteric, sacral, and ischial pressureulcers which are illustrated on FIG. 1B and occur on generally wide fatareas such as buttocks and back or venous ulcers of the medial aspect ofthe leg. Accordingly, the frame portion of the device has a wide smoothconcave surface 71 to correspond with the patient's wide concave surface72. As seen in FIG. 5A hooks or prongs 73A and 73B are situated inhealthy skin outward of the ulcerative portion 74. FIG. 5B shows thesame device wherein the hooks 73A and 73B have moved from their initialremote positions shown in FIG. 5A to their final and closely adjacentpositions, whereby the hooks have drawn together the healthy skin tojunction line 76.

FIGS. 6A and 6B show a still further embodiment 80 which has been shapedto accommodate the bulbous projection of an ankle with an ulcerativesite on the protruding portion. As shown this ulcerative site 81corresponds to the ankle ulcer shown in FIG. 1. Also FIG. 6A shows hooks82A and 82B in their initial remote position and the way they havepierced and engaged healthy skin. FIG. 6B shows the same device 80wherein hooks 82A and 82B have moved to their final near positionshaving traversed their respective paths 83A and 83B, and the healthyskin has been expanded, regenerated and brought together along junctionline 84 where it grows together in its healed state.

FIGS. 7A and 7B show a still further embodiment 90 which is a shortframe with a very mild curvature somewhat like the device of FIGS. 5Aand 5B, this one intended for application to an ulcerative site 91 onthe top or plantar surface of a patient's foot. Here the device has aconcave inner surface 92 to correspond to the contour of the patient'slimb 93. As before, the hooks 94A and 94B have penetrated healthy skinoutward of the ulcerative site 91. The length of the respective paths95A and 95B are relatively short; FIG. 7B shows that these paths havebeen traversed by the respective sliders 96A and 96B so that the havedrawn together the healthy skin to its new junction line 97.

FIGS. 8A and 8B show a still further version or embodiment 100 which isapplied to a body contour defining a generally 90° curve generally likethe embodiments shown in FIGS. 4A and 4B; however, the path 101 atlength L-1 is somewhat longer than the path 102 at length L-2, so thathook 101A travels a greater distance than hook 102A. This device is usedwhere the elasticity of the skin in the area of hook 101A is greaterthan the elasticity of the skin in the area of hook 102A. Thus, inoperation as shown in FIG. 8B, hook 101A arrives at its junction point103 with hook 102A at about the same time but after having travelled agreater distance. Springs 104A and 104B may be selected or adjusted asrequired as appropriate for the force of spring 104B to be less than104A because 104B is moving a lesser distance than 104A in the samegeneral time period.

With respect to all of these constant tension devices, the frame of thedevice which houses the hooks or staples must be properly situatedadjacent the ulcerative site and maintained in position during the timeperiod of the treatment. Any surface of these devices that comes intocontact with the ulcerative area or skin is covered with a pressureabsorbing material. FIG. 9 shows frame 110 situated with its concaveinner surface 111 adjacent to convex external surface 112 of the footwith hooks 113A and 113B penetrating healthy skin adjacent theulcerative site 114. The slides 115A and 115B move in their respectivetracks, and the frame 110 is maintained in its proper position andorientation with respect to the foot by a dressing 116. This dressingmay be layers of tape, gauze, or other appropriate material. Suchattaching means may wrap completely around the foot as shown or mayengage only a partial area of the foot as might be done with adhesivetape.

The force applied by dressing to secure the device to the foot isabsorbed by frame 110 which permits movement of sliders 115A and 115Bover the ulcerative site 114. Sliders 115A and 115B move independentlyand move at difference rates as they advance toward internal stops 116Aand 116B. Movement of sliders 115A and 115B is dependent upon theextensibility of the respective skin engaged by hooks 113A and 113B.Internal stops insure that skin is expanded from both sides of the woundby accommodating for the differences in skin ostensibilities. In skin ofhigher extensibility the slider will advance to the internal stopquickly and advance no further. This prevention of excess movement ofthe slider engaged to higher extensibility skin allows the sliderengaging skin of slightly lower extensibility to reach its internalstop, and therefore insures that skin is expanded from both sides of thewound.

FIG. 9 also illustrates the adjacent near ends 116A and 116B which arealso called internal stops for terminating movement of the sliders asthey approach each other. If desired other or additional stop elementscould be incorporated to adjust the length of each path for slidermovement.

FIG. 10 shows a still further embodiment 120 of the new device which isgenerally similar to others except that it includes a ratchet mechanismto allow stepwise movement of the slider forward but not rearward.Specifically, slider 121 slides in a unique path 122 which has asuccession of teeth 123 having as a saw tooth profile. The slider whichcarries its usual hook 124 also has at least one and preferably threemating teeth 125 for engagement with the teeth 123. Spring 126 pullsslider 121 in the direction of arrow 127 and teeth 125 engage with pathteeth 123 in a manner which allows the slider to move in direction 127as pulled by the spring; however, slider cannot return in the oppositedirection of arrow 128. Thus the hook and slider cannot move rearwardbeyond the last step should the tissue relax or stretch. The hook orstaple 124 may be a hollow tube as shown by section 124T thereof.

In FIG. 11 the frame 110 is separated from the top surface 112 of thefoot by a pressure absorbing material 130. This material is situated atleast along the bottom surface 111, but may also extend up the sides asseen at 131. With this arrangement the dressing 116 can hold the frame110 securely in place while distributing and easing pressure applied bythe bottom of the frame to the foot, and while permitting free movementof the sliders.

FIG. 12 shows a wound 142 having a peripheral edge 143 and two devices144 positioned above the wound. From each device extends a staple 145through incision 146. The staples' curved bottom or lead end 147 definesa plane oriented generally perpendicular to the longitudinal axis X--Xof the device.

FIG. 12A shows an enlarged detail of FIG. 12 with correspondingreference numbers. FIG. 12A shows more clearly the plane 148 includingaxis Y--Y which is perpendicular to axis X--X of the frame of thedevice.

FIG. 12B shows an end view of FIG. 12 as contrasted with FIG. 12C whichrepresents an end view of the device in FIG. 11. It is believed that thestaple 145 of FIG. 12B will push a larger area of mass of tissue moreeffectively than the staple 113A in FIG. 12C. The diameter of thestaples may vary, but the diameter of one preferred embodiment is 0.036inches. The staple may be metal or plastic formed as a thin, elongatedelement terminating in a sharp point.

With any of the embodiments disclosed herein a further variation is anadjustment means for varying the magnitude of the force of the spring,as opposed to a still further alternative of substituting a differentspring. For varying the spring force a threaded screw 135 is directedthrough the frame to apply friction on the spring and thus decrease thepulling force applied by the spring. A knob may be provided on theexposed opposite end of the screw to permit easy and accurate microadjustment of the spring force.

FIG. 13 shows another embodiment 151 of the invention with frame 150,slider 154, engaging means 152 and tool 155 for manual application offorce to slider 154, which is in addition to the spring force applied tothe slider.

The embodiments of the invention described herein are merely examples ofthe invention. Many variations and equivalents are possible within thespirit and scope of the invention as defined by the claims appendedhereto.

We claim:
 1. A constant tension tissue expansion and approximationdevice for helping to restore skin to an open wound area of a patientwho has relative healthier skin outward of and surrounding the openwound area, the device comprising:a) a frame including means thereonforming boundaries which define a path that extends in an axialdirection, the path having remote and near ends, the frame having anexposed bottom surface positionable to overlie the patient's skin, b) aslider coupled to said frame and movable along said path, where saidboundaries of the path define and control any non-axial displacement ofthe slider when it is moved axially along said path, c) engaging meanscarded by said slider for releasably engaging the healthier skin, and d)force application means for urging said slider to move in the directionof the path from said remote end of the path toward said near end of thepath, said force application means providing a generally continuousforce of generally constant magnitude on said slider regardless of thelocation of the slider along said path, and e) a layer of pressureabsorbing material secured to said exposed surface of said frame. 2.Apparatus according to claim 1 wherein said engaging means extendsdownward from said bottom surface of said frame and curves, this elementthus defining a plane.
 3. Apparatus according to claim 2 wherein saidplane extends generally perpendicular to the frame's axial pathdirection.
 4. A method for treating a patient's open wound which issurrounded by healthier skin, comprising:a) engaging at least one edgeof the healthier skin, b) urging the engaged edge of the healthier skinin a direction to cover the open wound, where said urging comprisesapplying a generally continuous first force of generally constantmagnitude to the engaged edge of the healthier skin, and c)supplementing said first force by applying a temporary manual secondforce at least once to the engaged skin in the same direction as saidfirst force and of magnitude slightly greater than said first force andsubsequently ceasing said second force and leaving only said firstforce.
 5. A method according to claim 4 comprising engaging oppositeedges of the healthier skin and simultaneously urging said engaged edgestoward each other according to steps b and c, until said engaged edgestogether cover the open wound and grow together.
 6. A tissue expansionand approximation device for helping to restore skin to an open woundarea of a patient who has relatively healthier skin outward of andsurrounding the open wound area, the device comprising:a) a frameincluding means thereon forming boundaries which define a path thatextends in an axial direction, the path having remote and near ends, theframe having an exposed bottom surface positionable to overlie thepatient's skin, b) a slider coupled to said frame and movable along saidpath, where said boundaries of the path define and control displacementof the slider when it is moved axially along said path, c) engagingmeans carried by said slider for releasably engaging the healthier skin,and d) force application means urging said slider to move in thedirection of the path from said remote end of the path toward said nearend of the path, said force application means providing a generallycontinuous force of generally constant magnitude on said sliderregardless of the location of the slider along said path, said engagingmeans comprising a stem that extends in a downward direction relative tosaid bottom surface of said frame and a pointed end, said stem andpointed end generally defining a plane that extends transversely of saidaxial direction.
 7. Apparatus according to claim 6 wherein said engagingmeans extends downward from said bottom surface of said frame andcurves, this element thus defining a plane.
 8. Apparatus according toclaim 6, wherein said plane extends generally perpendicularly of theframe's axial path.
 9. Apparatus according to claim 6 wherein said framedefines a curved path.
 10. A method for treating a patient's open woundwhich is surrounded by healthier skin, comprising:a) engaging at leastone edge of the healthier skin, b) urging the engaged edge of thehealthier skin in a direction to cover the open wound, where said urgingcomprises applying a generally continuous first force of generallyconstant magnitude to the engaged edge of the healthier skin, and c)supplementing said first force by applying a temporary second force atleast once to the engaged skin in the same direction as said first forceand of magnitude slightly greater than said first force and subsequentlyceasing said second force and leaving only said first force.